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Toric Contact Lens Digital Performance and Comfort Study

Not Applicable
Completed
Conditions
Astigmatism
Interventions
Device: Precision1 for Astigmatism
Device: Precision1 Sphere
Registration Number
NCT04772560
Lead Sponsor
Kathryn Richdale
Brief Summary

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

Detailed Description

This study seeks to quantify the near visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in an astigmatic cohort of patients. Primary Hypotheses: Subjects will have better near visual acuity and near visual performance with toric, as opposed to spherical, contact lens correction. As such, the following hypotheses will be tested: H01: There is no statistically significant difference in near visual acuity or near vision performance between contact lenses corrections Ha1: There is a statistically significant difference in visual acuity or vision performance between contact lenses corrections

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • 18 to 39 years of age (inclusive)
  • pl to -6.00D vertexed sphere power and -0.75 to -1.50D vertexed refractive cylinder OD and OS
  • Current/established full time (>6 days week, >8 hours/day) soft contact lens wearer
  • Best corrected acuity of 20/25 or better in each eye
  • Self-report of at least 4 hrs/day using digital devices
  • Willing to wear lenses at least 8 hours each day during the study period
  • Able to speak and read English at a high school level / have at least a high school diploma or equivalent (by self-report)

Enclusion Criteria:

  • History of ocular pathology or surgery
  • Binocular vision disorder (i.e., tropia, convergence or accommodative insufficiency)
  • Gas permeable lens wear for at least 3 months
  • Symptomatic soft contact lens wearer (CLDEQ-8 score <12 at baseline)
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Sphere, Then ToricPrecision1 SphereParticipants who received Spherical contact lenses first and Toric lenses after 10 days
Toric, Then SpherePrecision1 for AstigmatismParticipants who received Toric contact lenses first and spherical lenses after 10 days
Sphere, Then ToricPrecision1 for AstigmatismParticipants who received Spherical contact lenses first and Toric lenses after 10 days
Toric, Then SpherePrecision1 SphereParticipants who received Toric contact lenses first and spherical lenses after 10 days
Primary Outcome Measures
NameTimeMethod
Near Visual LogMAR Acuity10 +/- 2 days

High contrast LogMAR visual acuity was assessed at 40 cm using the M\&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly 10+/-2 days after each intervention. The test started at 20/60 and continued until three letters were missed on a line.

Dynamic Visual Acuity10 +/- 2 days

Dynamic VA was determined using a custom-made iPad application. The subject was instructed to hold the iPad at 40cm and presented with a Landolt C surrounded by crowding bars for 0.3s each, starting from 0.5 LogMAR and progressing to smaller sizes using a staircase threshold method. Testing was performed binocularly 10+/-2 days after each intervention

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Houston College of Optometry

🇺🇸

Houston, Texas, United States

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